The present invention relates to diagnostic kits and methods for the determination of antibodies in biological sample, typically urine. More particularly, it relates to methods and kits for detecting antibodies to microorganisms associated with sexually transmitted diseases.
Sexually transmitted diseases (STDs) include traditional venereal diseases such as syphilis, gonorrhea, chancroid, lymphogranuloma venereum, and granuloma inguinale. The term also encompasses a growing number of other diseases caused by human immunodeficiency viruses (HIV-1 and -2), hepatitis viruses, herpes simplex virus, Type II (HSV-2), and other viruses which have been reported to be sexually transmitted.
Most STDs do not exist as an isolated problem and multiple infections by a number of pathogens are common. The presence of an STD typically indicates high risk sexual behavior that is often associated with the risk of other more serious infections. The increasing importance of potentially incurable viral STDs (e.g. HIV infection) makes the early detection of any STD more crucial to reduce the transmission of these diseases. STDs are typically propagated in core populations with high levels of sexual activity and frequent changes of sexual partners.
In order to control the spread of these diseases, screening tests for gonorrhea, chlamydial infection, syphilis, and HIV infection must be inexpensive, widely available and safe. Most current detection methods rely on serological tests for the presence of antigens or antibodies to the particular pathogen. These assays rely on invasive procedures to obtain blood or serum from a patient suspected of having the disease. These procedures require relatively expensive equipment, such as sterile needles, syringes, skin cleanser and dressing, and in some cases may be hazardous to the health care personnel involved in collecting and analyzing the samples. Thus, there is an-urgent need for non-invasive, relatively inexpensive tests for the presence of pathogens associated with STDs.